Evaluation Ofe the Anxiolytic Effect of EMONO in Children During Dental Care (MOPEA)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Dental Care for Children

Treatments: Behavioral: Evaluate the anxiolytic effect during dental care with MEOPA in children

Study type: Observational

Funder types: Other

Identifiers

NCT03998774

RC17_0275

Details and patient eligibility

About

The EquiMolar Oxygen and Nitrous Oxyde mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. The University Hospital of Nantes is currently conducting a general evaluation of the EMONO use in the hospital context. The department of odontology is part of this movement and wants to study the anxiolytic effect expected during dental care under MEOPA in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.

Full description

The EquiMolar Oxygen and Nitrous Oxide Mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. It has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use and emergency vehicles; and indicated in the analgesia of short-term painful acts or during medical assistance. urgency in adults and children, dental sedation in children and frail subjects, and obstetrics. The actual benefit was considered important by the Transparency Committee.

Since 2009, a modification of the MAH for EMONO-based specialties has authorized their release from the hospital reserve, which can now be issued for professional use in city and dental surgery. Given the risks associated with the use of EMONO, in particular its potential for abuse and dependence, the ANSM conditioned its availability outside health facilities to the implementation of a common national RMP. This measure was also accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes.

The University Hospital of Nantes is currently conducting a general evaluation of the use of EMONO in the hospital context. The department of odontology is part of this movement and wants to study the anxiolytic effect expected during dental care under EMONO in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.

The analysis of this study will allow us to improve the good use of MEOPA for dental care.

Enrollment: 17 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children from 3 to 15 years,
• Requiring dental treatment under EMONO including local anesthesia
• Not opposed, as well as parents, to participate in the study
• Having a sufficiently cooperative attitude to allow the installation of the monitoring equipment
• The use of EMONO for dental care must be a first time for the child

Exclusion criteria

• The excluded patients will be those whose number of care is too important, justifying a general anesthesia. Similarly, patients who do not require anesthesia for their care will be excluded.